What ISO 11607 revisions mean to you (Part 2)
Karen Sams
Article Summary
Medical device manufacturers must take care up front with contractors and vendors to determine roles and responsibilities in the entire package development and validation process.
Most of the changes to the Standard will have little effect on how you design your packaging and sterile barrier systems for your devices. However, there are some nuances that will require additional testing and some subtleties for performing a final package system validation as described in Clause 6.
